- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02351154
Grading Atrophic Gastritis by Confocal Laser Endomicroscopy Probe (p-CLE)
Grading Atrophic Gastritis by a New Quantitative Method Using Confocal Laser Endomicroscopy Probe (p-CLE): First Results of a Prospective Cohort Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Consecutive patients that underwent to upper endoscopy (UE) evaluation were included in this study. All subjects went to UE according to standard procedure, under propofol sedation, and using a high definition endoscope with a working channel of 2.8 mm After gastric mucosa inspection using endoscopy, in vivo microscopy analysis at x1000 magnification was done using confocal laser endomicroscopy probe (p-CLE) in all patients.
During UE 5 biopsy sites were performed in accordance to update Sydney system first using p-CLE and them by biopsy forceps from the same site (2 from the lesser and greater curvature of the antrum about 2-3 cm near the pylorus, 2 from the middle portion of the lesser and greater curvatures of the corpus about 8 cm from the cardia, and 1 from the angulus). p-CLE images were recorded as video frames and pictures during in vivo microscopy analysis.
For histopathology all specimens were fixed in 10% formalin. An experienced histopathologist analyzed the histological features of each sample with hematoxylin and eosin staining and made the diagnosis according to the updated Sydney classification.
At p-CLE normal crypt was defined by using the classification of Wang et al. After histopathology confirm GA, crypts were analyzed using the CV software that is a post-procedure tool that could be installed in computers, working as a laboratory data analyzer. This software permits to measure diameters of the microscopy findings in an escalade model in micrometers, using different colors lines and giving their results in a table that could be exported as excel table for analysis of the results The crypts diameters were measuring to determine the area by using the elliptic area formula (A = π.d1.d2). The inter-crypt space was also measured and defined as the mean of each measured distance between the studied crypt and it's adjacent.
The cutoff value between mild, moderate and severe GA, crypts area was classified across tertiles, expressing its distribution using a box-spot graphic. For relationship between crypt area (CA) and inter-crypt space, quadratic polynomial regression was used. Data was processed using IBM® SPSS® Statistics.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Guayas
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Guayaquil, Guayas, Ecuador, 1301266
- Instituto Ecuatoriano de Enfermedades Digestivas
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- dyspepsia >12 months
- age ≥18, no history of UE evaluation
- GA at histopathology
- acceptance to participate.
Exclusion Criteria:
- use of proton pump inhibitors
- antibiotics or NSAID´s
- gastric cancer
- gastric surgery
- pregnancy
- contraindication to fluorescein.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Atrophic gastritis
gastric glands (crypts) with atrophic gastritis were measured using the Cellvizio Viewer software
|
permets to perform analysis of diameters in micrometers
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gastric crypt diameters
Time Frame: 3 months
|
to determine the area of the gastric crypt measured by the elliptic area formula (A = π.d1.d2)
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gastric inter-crypt diameters
Time Frame: 3 months
|
measuring the distance of the gastric inter-crypt space.
|
3 months
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Wang P, Ji R, Yu T, Zuo XL, Zhou CJ, Li CQ, Li Z, Li YQ. Classification of histological severity of Helicobacter pylori-associated gastritis by confocal laser endomicroscopy. World J Gastroenterol. 2010 Nov 7;16(41):5203-10. doi: 10.3748/wjg.v16.i41.5203.
- Zhang JN, Li YQ, Zhao YA, Yu T, Zhang JP, Guo YT, Liu H. Classification of gastric pit patterns by confocal endomicroscopy. Gastrointest Endosc. 2008 May;67(6):843-53. doi: 10.1016/j.gie.2008.01.036.
- Dixon MF, Genta RM, Yardley JH, Correa P. Classification and grading of gastritis. The updated Sydney System. International Workshop on the Histopathology of Gastritis, Houston 1994. Am J Surg Pathol. 1996 Oct;20(10):1161-81. doi: 10.1097/00000478-199610000-00001.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IECED 01-08-2014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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